Month: June 2021
Inspection procedure for Capsule :
|After line clearance, transfer the filled capsule in SS tray or on the inspection table layered with HDPE polythene bag and spread the capsules on inspection table.|
|Capsule should be visually checked for various defects (Dented, telescopic, Poor printing or no printing on capsules, Poor locking Quality, Improper polishing, Double caps Empty capsule etc) & Rejected capsules should be kept in Polythene bag containing online rejection label as per SOP of “Procedure for Status Labelling” .|
|Collect the good capsules in HDPE container lined with double polythene bags and weigh and label it properly as per Batch Manufacturing record|
|Summary of rejection quantity for various defect of capsule shall be recorded as per provision given in Batch Manufacturing record|
|Some Picture of various defect of capsule given below for clarity regarding distinguish the different types defect.|
An autoclave is a sterilization device that is widely used in in hospitals, Pharmaceutical industries and laboratories. Sterilization is critical within the pharmaceutical and medical industries.
How do Autoclave works :
An autoclave is a device that works on the principle of moist heat sterilisation, wherein saturated steam is generated under pressure in order to kill microorganisms such as bacteria, viruses, and even heat-resistant endospores from various types of instruments. This is done by heating the instruments within the device to temperatures surpassing the boiling point of water.
This process is also embodied by gas laws, which basically states that the higher the pressure is within the device, the higher the temperature increases. In other words, pressure and temperature are directly proportional to each other.
It is also important to note that it is the temperature that kills the microorganisms, not pressure. Rather, higher pressures are capable of increasing the boiling point of water, which thus increases the temperature of sterilization. High pressure also helps heat to rapidly spread within the material.
Autoclaves typically yield a temperature of about 121 degrees Celsius, taking about 15-20 minutes to complete the sterilization process. However, autoclave cycles may be adjusted accordingly by the working technician.
Autoclaves are grounded on three factors, namely: pressure, temperature, and time. These three factors all work together to create saturated steam, within a particular time frame, that can kill all signs of microbial life, whether they are in vegetative or spore form.
What is The Operating Procedure of Autoclave :
1). Check if there are previous instruments, Glass, stainless steel, cultures etc contained within the chamber.
2). Put water in the chamber and make sure it is the right amount.
3). Place the instruments, Glass, stainless steel, cultures etc inside the chamber which are required to be sterilized.
4). Close the lid and tighten the screws then switch on the electric heater.
5). Adjust the safety valves to maintain the required pressure level within the chamber.
6). Once the water within the chamber begins to boil, the air-water mixture can escape through the discharge tube in order to displace all the air inside. Complete displacement is evident when no more water bubbles come out from the pipe.
7). Close the drainage pipe and let the steam reach the desired level.
8). Once the pressure level has been reached, blow the whistle to remove all the excess pressure within the chamber.
9). Let the autoclave run for the set time period after the whistle.
10). Switch off the electric heater and let the autoclave cool until the pressure within the chamber has lowered down to the atmospheric pressure.
11). Open the discharge pipe to allow air from outside the autoclave to enter.
12). Open the lid and remove the instruments from the chamber.
The Stages of Autoclave Sterilization :
The sterilization process includes different phases
- Purge Phase : During this phase steam displaces air within the autoclave chamber and both temperature and pressure begin to increase
- Sterilization Phase : The exhaust remains closed, allowing the temperature and press to rapidly rise to the desired values. It is during this phase that autoclaves harsh conditions destroy bacteria, spores and other pathogens.
- Exhaust Phase : Pressure is released from chamber, but temperature remain high. Operator or microbiologist should take care when removing hot contents from autoclave.
Autoclave Compatible and Incompatible Materials
|Compatible Materials||Incompatible Materials|
|Biological cultures and stocks||Materials containing solvents, volatile or corrosive, or flammable chemicals|
|Culture dishes and related materials||Material contaminated with chemotherapeutic agents or cytotoxic drugs|
|Contaminated solid items (i.e. pipette tips, gloves, Petri dishes, etc.)||Material containing Bleach*|
|Discarded live (including attenuated) viruses/vaccines||Carcinogens or mutagens (i.e. ethidium bromide)|
|Polypropylene (PP) and polycarbonate (PC) plastics||Phenol and Trizol|
|Borosilicate glass||Polystyrene (PS), polyethylene (PE), and high-density polyethylene (HDPE) plastics|
|Stainless steel||Houshold glassware|
What is Equipment usage logbook :
The purpose of this Document is for Recording the usage, cleaning and maintenance activity of Equipment in a chronological order, with done by, checked and reviewed by signature.
Separate Equipment usage log shall be issued for each process Equipment and Issued Equipment usage log book shall be used for execution.
Equipment Logbook shall be the person who has done or perform the activity and shall be checked by another person for correctness.
- All equipment user logs shall be under the control of quality assurance department.
- The equipment user log shall contain the following details.
- Equipment information
- The first page of all equipment log shall contain the equipment information i.e., equipment name, equipment number, model and month.
- Equipment user log issued from quality assurance department on request of production.
- Equipment user log format.
- Equipment user log shall contain the details of user log (Annexure-1)
- Quality assurance department shall issue the equipment user log for equipment on rising of requisition slips fore equipment user log duly approved by In-charge /executive.
- The respective section In-charge shall verify the equipment user log.
- The executive Quality Assurance department shall review all the log for every 15 days. In case of any discrepancy, the same should be brought to the notice of the respective department In-charge for corrective action.
- The completed user log shall be returned to QA department.
- Document controller shall store the completed log.
Entries in user log :
- All the entries shall be made with black ballpoint pen.
- If any column is not applicable, enter NA in the respective column.
- Time shall be entered as hours round the clock. For ex: 12 AM shall be entered as 00.00 hour and 1:00 PM shall be entered as 13:00hour.
- Any events related to the instrument shall be entered in remarks column otherwise enter “Nil”.
- The respective department operator /executive shall fill all the columns in the user log before starting the procedure / analysis except end time and remarks column. End time and remarks column shall be filled after the completion of activity.
Correction of wrong entries:
For any error during entry, the following process followed and In case, any wrong entry occurs, strike it out with a single line.
Clearly write the correct entry near the wrong entry.
Sign and put the date on which the correction was made.
If an entire line has to be deleted, strike it out with a single line (horizontal/vertical).
Write a note explaining the reason for deletion with sign and date.
The section-in-charge shall verify and counter sign on the same.
Annex – 1 Equipment Usage Logbook